03.02.15
The New York Attorney General has accused GNC, Target, Walmart and Walgreens of selling store brand herbal supplement products that, according to controversial DNA barcoding analysis, either could not be verified to contain the labeled substance or were found to contain ingredients not listed on the labels.
Cease-and-desist letters called for the retailers to stop the sale of certain popular products, including Echinacea, ginseng, St. John’s Wort and others. Attorney General Eric Schneiderman requested the companies provide detailed information relating to the production, processing and testing of herbal supplements sold at their stores, as well as set forth a thorough explanation of quality control measures in place. He soon thereafter issued subpoenas to the four retailers demanding substantiation of label claims.
The attorney general’s office claimed DNA testing performed as part of an ongoing investigation showed just 21% of store brand herbal supplements evaluated actually contained DNA from the plants listed on product labels—with 79% coming up empty for DNA of labeled content, or were “contaminated” with other plant material.
In a statement, Mr. Schneiderman said, “This investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements. The DNA test results seem to confirm long-standing questions about the herbal supplement industry. Mislabeling, contamination, and false advertising are illegal. They also pose unacceptable risks to New York families—especially those with allergies to hidden ingredients. At the end of the day, American corporations must step up to the plate and ensure that their customers are getting what they pay for, especially when it involves promises of good health.”
A number of class-action lawsuits have been filed around the U.S. following reports about the AG’s allegations.
Industry Fires Back
Despite industry requests for public release of the testing data, no information had been published as of press time. GNC refuted the claims made by the New York AG, affirming the quality, purity and proper labeling of product lots.
In a statement, the company said it is offering “full and robust responses to every question raised in the letter, including original test results and the results of retesting that was performed on the product lots cited in the letter.”
“All GNC products are submitted to rigorous and generally accepted testing before they reach our customers,” said Michael Archbold, CEO of GNC. “When industry-wide standards are used to authenticate the ingredients in our products, the results demonstrate they are pure, safe and fully compliant. We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives.”
The retailer said it would continue to withhold the affected products in its New York stores temporarily, pending a timely response from the attorney general.
Industry experts questioned the analytical methods in this case, saying DNA barcoding is not a scientifically valid technology for determining the identity of botanical extracts in many dietary supplements.
The non-profit American Herbal Pharmacopoeia (AHP) sent Mr. Schneiderman a four-page letter with a 54-page addendum complete with technical data. The dossier provided widely recognized standard testing methodologies citing monographs of AHP, the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).
The addendum included national and international monographs for each of the seven herbal dietary supplements recently tested for the New York AG, highlighting the appropriate characteristics of each plant and extract. The communication acknowledged that adulteration of those products may exist in the marketplace but that the analytical technology used by Clarkson University for the AG likely did not accurately and adequately prove this.
The letter, signed by AHP Executive Director Roy Upton, stated in part, “With rare exception, DNA barcoding is not an appropriate technology for testing the identity of ingredients in extracts. By definition, extracts are made by extracting the desired constituents from the plant material itself into a liquid medium, a process that either does not maintain the DNA or significantly denatures it. The extract is then processed and dried onto an appropriate carrier. In that process, an extract is sometimes subjected to heating or further mechanical filtering, which similarly either removes or further denatures DNA if present. With most extracts there is no actual plant tissue left or, if any material remains, it can be greatly degraded. Because of this, there is either no DNA in finished products, such as those tested, or there is too little intact DNA to get an accurate finding.”
DNA barcodes are short genetic markers in an organism’s DNA and are used to identify it as belonging to a particular species. An expert in DNA barcoding technology, Dr. James Schulte II of Clarkson University in Potsdam, NY, was hired by the attorney general’s office to perform the testing.
The Council for Responsible Nutrition (CRN) criticized the AG’s actions, calling them a self-serving publicity stunt under the guise of protecting public health.
“Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial,” said Steve Mister, president and CEO of CRN. “Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards.”
Dietary supplement companies are required by law to adhere to Good Manufacturing Practices (GMPs), which include identity testing for all botanical materials used, he added. “Different identification test methods, from simple titration to chromatography and mass spectrometry, are appropriate for different stages of the processing—from the whole plant to the extract, to the finished product. Companies identify all incoming materials and keep records of these test results, and those test results could have been shared if companies had been approached in a reasonable manner with a reasonable timeframe. The FDA, which enforces these identity requirements through routine inspections, does not require DNA barcode testing; nor should it, given that this novel approach has not been validated for finished products.”
According to the AG, while overall 21% of the product tests confirmed DNA barcodes from the plant species listed on the labels, 35% of the product tests identified DNA barcodes from plant species not listed on the labels, representing “contaminants and fillers.” A large number of the tests did not reveal any DNA from a botanical substance of any kind. Some of the contaminants/fillers identified include rice, beans, pine, citrus, asparagus, primrose, wheat, houseplant, wild carrot and others. In many cases, unlisted contaminants were the only plant material found in the product samples, according to the AG.
Mr. Mister noted that the DNA testing method does not provide information on the amounts of food contaminants found in the products. “This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients like gluten, and trace amounts of DNA from rice, beans, pine, citrus, etc. are not considered harmful or required on labels. Announcing the detection of minute amounts of these substances unnecessarily alarms consumers without informing them whether the detection of DNA from these substances poses any allergic risk.”
Loren Israelsen, president of the United Natural Products Alliance (UNPA), also emphasized that a majority of the products tested using DNA analysis are plant extracts, which do not inherently contain intact DNA from the plant material. “This fact alone suggests that the majority of testing done is invalid. Working with our member companies, we will continue with our own internal testing of these products to determine whether we can confirm the results released by the New York attorney general’s office.”
The validity of the data is a central question, he added. “We are actively evaluating currently available data and will continue to make available our test results.”
ABC’s POV
The American Botanical Council (ABC) was contacted by New York Times writer Anahad O’Connor requesting a comment on the attorney general’s (then-embargoed) press release. Chief Science Officer of ABC and Technical Director of the ABC-AHP-NCNPR Botanical Adulterants Program Stefan Gafner, PhD, and ABC Founder and Executive Director Mark Blumenthal sent the following statement to Mr. O’Connor, which was not included in the Times’ articles that appeared online and on the front page of the New York Times (above the fold) on Feb. 2:
“The AG’s study is not based on adequate science and its actions are thus premature. The use of DNA barcoding technology for testing of the identity of botanical dietary supplements is a useful but limited technology. DNA testing seldom is able to properly identify chemically complex herbal extracts as little or no DNA is extracted in many commercial extraction processes. Basing its actions on the basis of only one testing technology from only one laboratory, the NY AG results are preliminary and require further substantiation. Additional testing using microscopic analysis and validated chemical methods should be conducted to confirm the initial results upon which the AG is acting.”
ABC also added the following statement based on recently published DNA studies on commercial ginkgo extracts conducted at the New York Botanical Garden and the University of Mississippi’s National Center for Natural Product Research:
“The AG’s test results do not comport with other recently published research on herbal dietary supplements. Two recent tests from reputable laboratories on commercial ginkgo extracts have found ginkgo in all or almost all of the samples tested.”
According to Mr. Blumenthal, “From a scientific perspective, it appears that the NY AG is way out in front of the available scientific evidence to support and substantiate his position. We cannot know this for certain until we know more about the testing protocols, but in general, as we told the New York Times, DNA barcode testing often cannot determine the identity of a botanical material if it’s been extracted, or if the material has been submitted to a prolonged heat treatment,” he continued, “so, if any of the products tested were extracts—e.g., ginkgo, and possibly the St. John’s wort products—then it’s understandable why they got a negative finding. This also may be true for other products tested, i.e., if they were extracts.”
“Further,” said Dr. Gafner, “it seems as if there wasn’t any verification of the results. As we noted in the statement to the New York Times, microscopy and validated chemical test methods, like those found in official pharmacopeias for these seven herbs, should have been conducted to confirm the DNA findings. The best way to determine the identity of botanical materials and ingredients in finished supplements is to use a range of appropriate methods whenever possible.”
“The action by the New York attorney general is highly problematic,” Mr. Blumenthal added. “We here at ABC are sympathetic with the AG’s obvious concern about the reported problems associated with adulteration of herbal ingredients in dietary supplements. After all, ABC is the international leader in educating the industry, researchers and health professionals about the problems associated with adulterated botanical ingredients through our leadership of the ABC-AHP-NCNPR Botanical Adulterants Program. However, everything we are doing in our program is based on scientific research, including evaluation of appropriate testing methods, and full peer review. We respectfully must question whether an appropriate level of scientific rigor has been applied in this case.”
“The New York AG should take every precaution to approach potential ways to deal with this problem by using appropriate protocols, including an extensive review by competent scientists who are familiar with the analysis of botanical dietary supplements,” added Dr. Gafner. “Conducting DNA tests with little or no apparent verification by other test methods, and without employing a second or even a third analytical laboratory to confirm the findings of the first lab results, and then proceeding to engage in regulatory activity is premature based on the evidence they have collected and disclosed thus far. Additional testing in another qualified DNA lab as well as by other appropriate and validated testing methods is required.”
Dr. Gafner emphasized that although some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication. Other processes, such as extensive heat treatment or submission of plant material to UV light also impact the quality and may lead to erroneous results using DNA methods.
“If, when the dust settles on this issue and all appropriate analytical methods and protocols are used to test these products, and they still confirm the NY AG’s initial tests, only then should the New York AG (and the Food and Drug Administration) pursue appropriate legal and regulatory enforcement options,” said Mr. Blumenthal. “However,” he continued, “that can happen only when all appropriate tests are run by people who are expert in the testing of plant materials. Based on what we can determine, that hasn’t occurred here.”
Subpoena Questions Claims
Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), and former director of the Division of Dietary Supplement Programs at FDA, said NPA views the attorney general’s subpoena for evidence to support label claims “as yet another form of harassment against an industry that serves hundreds of millions of Americans safely and effectively each day.”
“The attorney general is using these subpoenas as a misdirection, removing focus from the fact that he still has yet to release the data from the DNA study he used as the basis for his original cease-and-desist.”
The products in question contain some of the most widely researched ingredients in the industry, Dr. Fabricant noted. “Ingredients such as St. John’s Wort, Ginkgo biloba, ginseng and Echinacea have droves of scientific research behind them, which is readily available on ClinicalTrials.gov. The multiple clinical studies on these types of products support and substantiate the physical benefits of these ingredients made in structure/function claims.”
Federal laws and statutes already require supplement firms to make claims that are truthful and not misleading; obtain competent and reliable scientific evidence for claim substantiation; and file a 30-day structure/function notification for each claim made for dietary supplement products.
“If Attorney General Schneiderman were properly informed in this area, he would have pursued action against products making egregious weight-loss claims or those with ingredients with little science behind them, as that is exactly what the Federal Trade Commission does and with much success. Since the attorney general appears to be more focused on making headlines than actually protecting consumers, he foolishly went after ingredients with hundreds of clinical studies behind them.”
Cease-and-desist letters called for the retailers to stop the sale of certain popular products, including Echinacea, ginseng, St. John’s Wort and others. Attorney General Eric Schneiderman requested the companies provide detailed information relating to the production, processing and testing of herbal supplements sold at their stores, as well as set forth a thorough explanation of quality control measures in place. He soon thereafter issued subpoenas to the four retailers demanding substantiation of label claims.
The attorney general’s office claimed DNA testing performed as part of an ongoing investigation showed just 21% of store brand herbal supplements evaluated actually contained DNA from the plants listed on product labels—with 79% coming up empty for DNA of labeled content, or were “contaminated” with other plant material.
In a statement, Mr. Schneiderman said, “This investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements. The DNA test results seem to confirm long-standing questions about the herbal supplement industry. Mislabeling, contamination, and false advertising are illegal. They also pose unacceptable risks to New York families—especially those with allergies to hidden ingredients. At the end of the day, American corporations must step up to the plate and ensure that their customers are getting what they pay for, especially when it involves promises of good health.”
A number of class-action lawsuits have been filed around the U.S. following reports about the AG’s allegations.
Industry Fires Back
Despite industry requests for public release of the testing data, no information had been published as of press time. GNC refuted the claims made by the New York AG, affirming the quality, purity and proper labeling of product lots.
In a statement, the company said it is offering “full and robust responses to every question raised in the letter, including original test results and the results of retesting that was performed on the product lots cited in the letter.”
“All GNC products are submitted to rigorous and generally accepted testing before they reach our customers,” said Michael Archbold, CEO of GNC. “When industry-wide standards are used to authenticate the ingredients in our products, the results demonstrate they are pure, safe and fully compliant. We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives.”
The retailer said it would continue to withhold the affected products in its New York stores temporarily, pending a timely response from the attorney general.
Industry experts questioned the analytical methods in this case, saying DNA barcoding is not a scientifically valid technology for determining the identity of botanical extracts in many dietary supplements.
The non-profit American Herbal Pharmacopoeia (AHP) sent Mr. Schneiderman a four-page letter with a 54-page addendum complete with technical data. The dossier provided widely recognized standard testing methodologies citing monographs of AHP, the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).
The addendum included national and international monographs for each of the seven herbal dietary supplements recently tested for the New York AG, highlighting the appropriate characteristics of each plant and extract. The communication acknowledged that adulteration of those products may exist in the marketplace but that the analytical technology used by Clarkson University for the AG likely did not accurately and adequately prove this.
The letter, signed by AHP Executive Director Roy Upton, stated in part, “With rare exception, DNA barcoding is not an appropriate technology for testing the identity of ingredients in extracts. By definition, extracts are made by extracting the desired constituents from the plant material itself into a liquid medium, a process that either does not maintain the DNA or significantly denatures it. The extract is then processed and dried onto an appropriate carrier. In that process, an extract is sometimes subjected to heating or further mechanical filtering, which similarly either removes or further denatures DNA if present. With most extracts there is no actual plant tissue left or, if any material remains, it can be greatly degraded. Because of this, there is either no DNA in finished products, such as those tested, or there is too little intact DNA to get an accurate finding.”
DNA barcodes are short genetic markers in an organism’s DNA and are used to identify it as belonging to a particular species. An expert in DNA barcoding technology, Dr. James Schulte II of Clarkson University in Potsdam, NY, was hired by the attorney general’s office to perform the testing.
The Council for Responsible Nutrition (CRN) criticized the AG’s actions, calling them a self-serving publicity stunt under the guise of protecting public health.
“Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial,” said Steve Mister, president and CEO of CRN. “Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards.”
Dietary supplement companies are required by law to adhere to Good Manufacturing Practices (GMPs), which include identity testing for all botanical materials used, he added. “Different identification test methods, from simple titration to chromatography and mass spectrometry, are appropriate for different stages of the processing—from the whole plant to the extract, to the finished product. Companies identify all incoming materials and keep records of these test results, and those test results could have been shared if companies had been approached in a reasonable manner with a reasonable timeframe. The FDA, which enforces these identity requirements through routine inspections, does not require DNA barcode testing; nor should it, given that this novel approach has not been validated for finished products.”
According to the AG, while overall 21% of the product tests confirmed DNA barcodes from the plant species listed on the labels, 35% of the product tests identified DNA barcodes from plant species not listed on the labels, representing “contaminants and fillers.” A large number of the tests did not reveal any DNA from a botanical substance of any kind. Some of the contaminants/fillers identified include rice, beans, pine, citrus, asparagus, primrose, wheat, houseplant, wild carrot and others. In many cases, unlisted contaminants were the only plant material found in the product samples, according to the AG.
Mr. Mister noted that the DNA testing method does not provide information on the amounts of food contaminants found in the products. “This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients like gluten, and trace amounts of DNA from rice, beans, pine, citrus, etc. are not considered harmful or required on labels. Announcing the detection of minute amounts of these substances unnecessarily alarms consumers without informing them whether the detection of DNA from these substances poses any allergic risk.”
Loren Israelsen, president of the United Natural Products Alliance (UNPA), also emphasized that a majority of the products tested using DNA analysis are plant extracts, which do not inherently contain intact DNA from the plant material. “This fact alone suggests that the majority of testing done is invalid. Working with our member companies, we will continue with our own internal testing of these products to determine whether we can confirm the results released by the New York attorney general’s office.”
The validity of the data is a central question, he added. “We are actively evaluating currently available data and will continue to make available our test results.”
ABC’s POV
The American Botanical Council (ABC) was contacted by New York Times writer Anahad O’Connor requesting a comment on the attorney general’s (then-embargoed) press release. Chief Science Officer of ABC and Technical Director of the ABC-AHP-NCNPR Botanical Adulterants Program Stefan Gafner, PhD, and ABC Founder and Executive Director Mark Blumenthal sent the following statement to Mr. O’Connor, which was not included in the Times’ articles that appeared online and on the front page of the New York Times (above the fold) on Feb. 2:
“The AG’s study is not based on adequate science and its actions are thus premature. The use of DNA barcoding technology for testing of the identity of botanical dietary supplements is a useful but limited technology. DNA testing seldom is able to properly identify chemically complex herbal extracts as little or no DNA is extracted in many commercial extraction processes. Basing its actions on the basis of only one testing technology from only one laboratory, the NY AG results are preliminary and require further substantiation. Additional testing using microscopic analysis and validated chemical methods should be conducted to confirm the initial results upon which the AG is acting.”
ABC also added the following statement based on recently published DNA studies on commercial ginkgo extracts conducted at the New York Botanical Garden and the University of Mississippi’s National Center for Natural Product Research:
“The AG’s test results do not comport with other recently published research on herbal dietary supplements. Two recent tests from reputable laboratories on commercial ginkgo extracts have found ginkgo in all or almost all of the samples tested.”
According to Mr. Blumenthal, “From a scientific perspective, it appears that the NY AG is way out in front of the available scientific evidence to support and substantiate his position. We cannot know this for certain until we know more about the testing protocols, but in general, as we told the New York Times, DNA barcode testing often cannot determine the identity of a botanical material if it’s been extracted, or if the material has been submitted to a prolonged heat treatment,” he continued, “so, if any of the products tested were extracts—e.g., ginkgo, and possibly the St. John’s wort products—then it’s understandable why they got a negative finding. This also may be true for other products tested, i.e., if they were extracts.”
“Further,” said Dr. Gafner, “it seems as if there wasn’t any verification of the results. As we noted in the statement to the New York Times, microscopy and validated chemical test methods, like those found in official pharmacopeias for these seven herbs, should have been conducted to confirm the DNA findings. The best way to determine the identity of botanical materials and ingredients in finished supplements is to use a range of appropriate methods whenever possible.”
“The action by the New York attorney general is highly problematic,” Mr. Blumenthal added. “We here at ABC are sympathetic with the AG’s obvious concern about the reported problems associated with adulteration of herbal ingredients in dietary supplements. After all, ABC is the international leader in educating the industry, researchers and health professionals about the problems associated with adulterated botanical ingredients through our leadership of the ABC-AHP-NCNPR Botanical Adulterants Program. However, everything we are doing in our program is based on scientific research, including evaluation of appropriate testing methods, and full peer review. We respectfully must question whether an appropriate level of scientific rigor has been applied in this case.”
“The New York AG should take every precaution to approach potential ways to deal with this problem by using appropriate protocols, including an extensive review by competent scientists who are familiar with the analysis of botanical dietary supplements,” added Dr. Gafner. “Conducting DNA tests with little or no apparent verification by other test methods, and without employing a second or even a third analytical laboratory to confirm the findings of the first lab results, and then proceeding to engage in regulatory activity is premature based on the evidence they have collected and disclosed thus far. Additional testing in another qualified DNA lab as well as by other appropriate and validated testing methods is required.”
Dr. Gafner emphasized that although some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication. Other processes, such as extensive heat treatment or submission of plant material to UV light also impact the quality and may lead to erroneous results using DNA methods.
“If, when the dust settles on this issue and all appropriate analytical methods and protocols are used to test these products, and they still confirm the NY AG’s initial tests, only then should the New York AG (and the Food and Drug Administration) pursue appropriate legal and regulatory enforcement options,” said Mr. Blumenthal. “However,” he continued, “that can happen only when all appropriate tests are run by people who are expert in the testing of plant materials. Based on what we can determine, that hasn’t occurred here.”
Subpoena Questions Claims
Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), and former director of the Division of Dietary Supplement Programs at FDA, said NPA views the attorney general’s subpoena for evidence to support label claims “as yet another form of harassment against an industry that serves hundreds of millions of Americans safely and effectively each day.”
“The attorney general is using these subpoenas as a misdirection, removing focus from the fact that he still has yet to release the data from the DNA study he used as the basis for his original cease-and-desist.”
The products in question contain some of the most widely researched ingredients in the industry, Dr. Fabricant noted. “Ingredients such as St. John’s Wort, Ginkgo biloba, ginseng and Echinacea have droves of scientific research behind them, which is readily available on ClinicalTrials.gov. The multiple clinical studies on these types of products support and substantiate the physical benefits of these ingredients made in structure/function claims.”
Federal laws and statutes already require supplement firms to make claims that are truthful and not misleading; obtain competent and reliable scientific evidence for claim substantiation; and file a 30-day structure/function notification for each claim made for dietary supplement products.
“If Attorney General Schneiderman were properly informed in this area, he would have pursued action against products making egregious weight-loss claims or those with ingredients with little science behind them, as that is exactly what the Federal Trade Commission does and with much success. Since the attorney general appears to be more focused on making headlines than actually protecting consumers, he foolishly went after ingredients with hundreds of clinical studies behind them.”
